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Merck has asked for FDA approval on a partial addition to OTC for adults 18 years old and older only, and only for the treatment of allergy symptoms, with specific wording that it not be used OTC for asthma treatment and specific warning that it not be used for children younger than 18 years. On a question before the committee regarding whether the safety of OTC use for relief of allergy symptoms, considering off-label use, been adequately demonstrated, 11 purchase montelukast members voted no and 4 voted yes. Merck has asked the FDA to add ocular symptoms of allergies in the indication, along with currently approved language on daytime nasal symptom relief, to the OTC labeling, but FDA staff members took that option off the table for the advisory committee vote. But no countries have approved it for OTC use. But it is what is still unknown that led to committee members' decisions, particularly with regard to potential off-label use for asthma patients and for pediatric patients, as well as potential neuropsychiatric adverse effects, including suicide.

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